Fecal IncontinenceNCT05626816
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
A study testing Genital Nerve Stimulation, Clinical exam and Collection of SCI common data elements in people with Fecal Incontinence, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Genital Nerve Stimulation, Clinical exam and Collection of SCI common data elements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic SCI
- Minimum 6 months post-injury
- Aged 18 years or older
- Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
- Response to genital nerve stimulation upon screening
- Able to understand and provide informed consent
Who cannot join
- Currently enrolled in another functional electrical stimulation (FES) research trial
- Females who are pregnant or planning to become pregnant during the trial
- Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
- In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MetroHealth Medical System Old Brooklyn Campus
Cleveland, Ohio, 44109
Mayson Moore, 2169573558, MMoore12@metrohealth.org
Robert Hoey, PhD, 2169573665, rhoey@metrohealth.org
About this study
Official title: Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
Read the detailed description
Time commitment: A person who participates in this study will have the option of coming in for one or two visits (for a total of about 7.5 hours). Descriptions below will separate the research activities into two visits for clarity.
Minimizing barriers to participation:
- - If you live in the region (Cuyahoga, Lorain, Medina, Lake, or Geauga counties of Ohio) and need assistance with transportation to get to and from the research site for a visit, the study team will make these arrangements at no cost to you. If you live outside of the region, the study team will reimburse your transportation expenses up to a maximum of $556 per visit.
- - If you live a distance away from the research site for which it would be easier for you to spend the night closer for a research visit, accessible lodging is available at the Zubizarreta House. This house is right next door to the MetroHealth Rehabilitation Institute and is designed for people with spinal cord injuries. The overnight stay will be provided at no cost to you, but if you need a caregiver to stay with you that is your responsibility.
Visit 1 (screening): When a person decides to participate in the study they will be scheduled to come in for a screening visit. During this visit they will: provide informed consent to participate, participate in the initial screening exams, and have genital nerve stimulation (GNS) applied briefly to determine if the nerve responds to electrical stimulation.
If a person completes the screening procedures and qualifies for the study they will be invited back to complete the manometry visit.
Visit 2 (manometry):
- - Preparation: the participant will be asked to complete their typical bowel program the night before their manometry visit is scheduled. There are no restrictions on medications, eating, or drinking prior to the visit.
- - Instrumentation: the participant will have the study instrumentation applied.
- - Testing procedures with ARM and GNS: The London classification protocol will be used to assess ano-rectal function. This procedure uses a short (~12 minutes) procedure of actions to determine how the anus and rectum are functioning.
Overall design: GNS and the London classification system will be used to assess bowel function in two different states, with stimulation and without stimulation. This will be applied in the order of no stimulation (condition A), stimulation (condition B), no stimulation (condition A repeated).
- Conditions
- Fecal Incontinence
- Being tested
- Genital Nerve Stimulation, Clinical exam, Collection of SCI common data elements, Bowel function survey completion, International Standard for Neurological Classification of SCI (ISNCSCI)
- Keywords
- bowel, spinal cord injury, electrical stimulation, anorectal manometry, incontinence, tetraplegia, paraplegia, paralysis
- Medical subject headings
- Fecal Incontinence, Spinal Cord Injuries, Quadriplegia, Paraplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genital Nerve StimulationDevice
Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.
Clinical examDiagnostic test
Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
Collection of SCI common data elementsDiagnostic test
Data regarding participant demographics, history of injury, and medical history will be collected.
Bowel function survey completionDiagnostic test
Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.
International Standard for Neurological Classification of SCI (ISNCSCI)Diagnostic test
The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D.
Response to genital nerve stimulation (GNS)Diagnostic test
GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS.
Anorectal Manometry testing (ARM)Diagnostic test
The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites.
Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and cough) as well as inflating the balloon on the catheter to determine reflex thresholds (RAIR, retroanal inhibitory reflex which relaxes the anal sphincter in response to rectal distension) and sensory thresholds (first senstation,
| Study group | Role | What they receive |
|---|---|---|
| All interventions, Sham applied first | Experimental | These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions. Receives: Device: Genital Nerve Stimulation; Diagnostic Test: Clinical exam; Diagnostic Test: Collection of SCI common data elements; Diagnostic Test: Bowel function survey completion; Diagnostic Test: International Standard for Neurological Classification of SCI (ISNCSCI); Diagnostic Test: Response to genital nerve stimulation (GNS); Diagnostic Test: Anorectal Manometry testing (ARM) |
| All interventions, effective stim applied first | Experimental | These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions. Receives: Device: Genital Nerve Stimulation; Diagnostic Test: Clinical exam; Diagnostic Test: Collection of SCI common data elements; Diagnostic Test: Bowel function survey completion; Diagnostic Test: International Standard for Neurological Classification of SCI (ISNCSCI); Diagnostic Test: Response to genital nerve stimulation (GNS); Diagnostic Test: Anorectal Manometry testing (ARM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARM outcome - Rectal wall tension
When an organ relaxes during filling it is called compliance and is characteristic of the rectum and bladder. This allows the organ to hold more material and therefore have a larger void when emptying. After SCI, organs that have had their control systems damaged become spastic and hyperreflexive which leads to smaller volumes and incontinence issues in both bladder and bowel function.
By inflating the ARM balloon with air we can slightly distend the rectum and measure the pressure (cmH20) to determine compliance. If the pressure stays the same after inflating the balloon then the rectum has relaxed and it is a measure of compliance. Rectal wall tension will be inferred from this response and abnormal tension will be apparent by reduced compliance (pressure increases when balloon volume increases).
This measure will be recorded with and without stimulation.
Measured: Up to three weeks after enrollment
ARM outcome - Anal sphincter function
Circumferential sensors on the ARM balloon catheter will detect pressure changes (cmH20) in the anal sphincter during cough, push, squeeze, and rest. Anal sphincter function will be assessed with and without stimulation.
Measured: Up to three weeks after enrollment
ARM outcome - Rectoanal reflex activity (RAIR)
Air will be infused into the ARM balloon to distend the rectum. When the rectum is distended the anal sphincter relaxes (rectoanal inhibitory reflex) and the amount of air required to elicit the reflex (cc) will be assessed with and without stimulation.
Measured: Up to three weeks after enrollment
ARM outcome - Rectal sensation
Air is infused (50 ml steps) into the ARM balloon until the participant reports: first sensation, urge to defecate, maximum tolerable sensation. The volume of air (cc) is recorded for each sensory event with and without stimulation.
Measured: Up to three weeks after enrollment
ARM outcome - Presence of hyper reflexive rectal contractions
After SCI the rectum become hyperreflexive and spastic. A major cause of fecal incontinence after injury is the result of these reflexive contractions and the inability to contract the external sphincter to maintain continence. This combination causes the rectum to expel small amounts of stool rather than storing the material for a larger bowel movement.
We will quantify the rectal pressure traces for reflexive contractions and measure their frequency (Hz or count/minute, whichever is most appropriate). Reflexive contractions will be steep increases in rectal pressure while at rest or during distension (sensation and RAIR testing). Measurements will be collected with and without stimulation and compared.
Measured: Up to three weeks after enrollment
Secondary outcomes (11)
SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)
A survey on bowel management difficulties and the effect of those complications on the participants quality of life will be conducted and data collected by study staff. Answers are chosen from a 5-point Likert scale from 1 (never/not at all) to 5 (always/very much) and higher scores represent greater difficulty managing bowel complications.
Measured: During enrollment, up to one week
International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)
A survey on bowel function after SCI will be conducted and data collected by study staff. The instrument is on a scale from 0-45 with higher scores indicating greater dysfunction.
Measured: During enrollment, up to one week
International Standards of Neurological Classification of SCI (ISNCSCI)
This is a standard assessment tool to determine level and severity of injury by the American Spinal Injury Association. The test uses pin prick and light touch to determine motor and sensory capability along the body. At the end of the test the participant will have information on their level (i.e. T8) and severity (grade A-D, with A being motor and sensory complete injury). These endpoints overlap with the clinical exam outcomes and will only be conducted once. Therefore, the ISNCSCI is being conducted in the context of the clinical exam endpoints below.
Measured: During enrollment, up to one week
SCI Common Data Elements - Medical history
Data will be collected regarding body system categories (constitutional symptoms, eyes, ears/nose/mouth/throat, cardiovascular, respiratory, gastrointestinal, genitourinary, musculoskeletal, integumentary, neurological, psychiatric, endocrine, hematologic/lymphatic, and allergic/immunologic) including start date, end date, and ongoing status.
Measured: During enrollment, up to one week
SCI Common Data Elements - History of injury
Data regarding the injury etiology and time frame will be collected from the participant.
Measured: During enrollment, up to one week
SCI Common Data Elements - Demographics
Data regarding the participants' gender, birth date, race, ethnicity, marital status, number of members in household, area of residence, number of years of education, and primary occupation.
Measured: During enrollment, up to one week
Clinical exam - abdominal exam
An SCI-specialized clinician will assess the participant in regard to abdominal health. This data will be incorporated into a clinical characterization of bowel dysfunction.
Measured: During enrollment, up to one week
Clinical exam - Evaluation of sacral reflexes
An SCI-specialized clinician will assess the participant in regard to the integrity of the sacral reflexes. These include the pudendo-anal reflex (PA) and bulbocavernosus (BC) reflexes that are critical for responding to the genital nerve stimulation.
Measured: During enrollment, up to one week
Clinical exam - Anal sphincter tone
An SCI-specialized clinician will assess the participant in regard to anal sphincter tone. After injury the external anal sphincter is either spastic (tightly closed and difficult to relax) or flaccid (completely lax and does not contract) based on the level of injury. If the damage to the spinal cord is at the level of the sacrum (just above the tailbone area) it will cause a flaccid phenotype and indicates damage to the reflex pathways necessary for the experiment.
Measured: During enrollment, up to one week
Clinical exam - Sensation
An SCI-specialized clinician will assess the participant in regard to areas of the body that have sensation. This data is incorporated in the ISNCSCI test and will not be duplicated.
Measured: During enrollment, up to one week
Clinical exam - Voluntary contraction
An SCI-specialized clinician will assess the participant in regard to the lowest area of the body that the participant is able to contract voluntarily. This data is incorporated in the ISNCSCI test and will not be duplicated.
Measured: During enrollment, up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start21 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive the intervention, but randomization will determine the order of presentation of sham and effective stimulation to ensure blinding of the participant.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VA of Northeast Ohio Health System, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Robert Hoey, MetroHealth Medical Center
- Investigators
- Kim Anderson, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626816
- Sponsor's protocol ID
- STUDY00000105
- Other IDs
- CDMRP-SC210121P1, CDMRP-SC210121
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A deidentified set will be transferred to the Inter-University Consortium for Political and Social Research (ICPSR) for data sharing and long-term preservation.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05626816
- Acronym / sponsor ID
- STUDY00000105
- Conditions
- Fecal Incontinence
- Keywords
- bowel, spinal cord injury, electrical stimulation, anorectal manometry, incontinence, tetraplegia, paraplegia, paralysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- VA of Northeast Ohio Health System, Congressionally Directed Medical Research Programs
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
Detailed description
Time commitment: A person who participates in this study will have the option of coming in for one or two visits (for a total of about 7.5 hours). Descriptions below will separate the research activities into two visits for clarity.
Minimizing barriers to participation:
- - If you live in the region (Cuyahoga, Lorain, Medina, Lake, or Geauga counties of Ohio) and need assistance with transportation to get to and from the research site for a visit, the study team will make these arrangements at no cost to you. If you live outside of the region, the study team will reimburse your transportation expenses up to a maximum of $556 per visit.
- - If you live a distance away from the research site for which it would be easier for you to spend the night closer for a research visit, accessible lodging is available at the Zubizarreta House. This house is right next door to the MetroHealth Rehabilitation Institute and is designed for people with spinal cord injuries. The overnight stay will be provided at no cost to you, but if you need a caregiver to stay with you that is your responsibility.
Visit 1 (screening): When a person decides to participate in the study they will be scheduled to come in for a screening visit. During this visit they will: provide informed consent to participate, participate in the initial screening exams, and have genital nerve stimulation (GNS) applied briefly to determine if the nerve responds to electrical stimulation.
If a person completes the screening procedures and qualifies for the study they will be invited back to complete the manometry visit.
Visit 2 (manometry):
- - Preparation: the participant will be asked to complete their typical bowel program the night before their manometry visit is scheduled. There are no restrictions on medications, eating, or drinking prior to the visit.
- - Instrumentation: the participant will have the study instrumentation applied.
- - Testing procedures with ARM and GNS: The London classification protocol will be used to assess ano-rectal function. This procedure uses a short (~12 minutes) procedure of actions to determine how the anus and rectum are functioning.
Overall design: GNS and the London classification system will be used to assess bowel function in two different states, with stimulation and without stimulation. This will be applied in the order of no stimulation (condition A), stimulation (condition B), no stimulation (condition A repeated).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will receive the intervention, but randomization will determine the order of presentation of sham and effective stimulation to ensure blinding of the participant.
| Arm | Type | Receives |
|---|---|---|
| All interventions, Sham applied first | Experimental | Device: Genital Nerve Stimulation, Diagnostic Test: Clinical exam, Diagnostic Test: Collection of SCI common data elements, Diagnostic Test: Bowel function survey completion, Diagnostic Test: International Standard for Neurological Classification of SCI (ISNCSCI), Diagnostic Test: Response to genital nerve stimulation (GNS), Diagnostic Test: Anorectal Manometry testing (ARM)These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions. |
| All interventions, effective stim applied first | Experimental | Device: Genital Nerve Stimulation, Diagnostic Test: Clinical exam, Diagnostic Test: Collection of SCI common data elements, Diagnostic Test: Bowel function survey completion, Diagnostic Test: International Standard for Neurological Classification of SCI (ISNCSCI), Diagnostic Test: Response to genital nerve stimulation (GNS), Diagnostic Test: Anorectal Manometry testing (ARM)These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Traumatic SCI
- Minimum 6 months post-injury
- Aged 18 years or older
- Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
- Response to genital nerve stimulation upon screening
Key exclusion criteria (4 listed)
- Currently enrolled in another functional electrical stimulation (FES) research trial
- Females who are pregnant or planning to become pregnant during the trial
- Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
- In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genital Nerve StimulationElectrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation. | Device | All interventions, Sham applied first, All interventions, effective stim applied first |
| Clinical examExamination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect. | Diagnostic test | All interventions, Sham applied first, All interventions, effective stim applied first |
| Collection of SCI common data elementsData regarding participant demographics, history of injury, and medical history will be collected. | Diagnostic test | All interventions, Sham applied first, All interventions, effective stim applied first |
| Bowel function survey completionTwo surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life. | Diagnostic test | All interventions, Sham applied first, All interventions, effective stim applied first |
| International Standard for Neurological Classification of SCI (ISNCSCI)The physician will conduct the ISNCSCI to determine the level and severity of injury to the spinal cord. This is done by determining the ability to detect light touch and pinprick stimulation. Outcomes will be a Spinal Injury Association Impairment Scale (AIS) grade of A-D. | Diagnostic test | All interventions, Sham applied first, All interventions, effective stim applied first |
| Response to genital nerve stimulation (GNS)GNS will be applied to determine if there is a response in the participant. If the participant has no response to the stimulation they will be excluded from the second visit as it is dependent on the ability to respond to GNS. | Diagnostic test | All interventions, Sham applied first, All interventions, effective stim applied first |
| Anorectal Manometry testing (ARM)The participant will be instrumented for ARM testing. This requires a special balloon catheter to be inserted into the anus and secured, surface electrode pads being applied to the anal sphincter, and electrode pads being applied to the genital nerve stimulation sites. Once instrumented, the participant will be tested with the London Classification procedure. This procedure asks the participant to perform several actions (squeeze to withhold a bowel movement, push to have a bowel movement, and cough) as well as inflating the balloon on the catheter to determine reflex thresholds (RAIR, retroanal inhibitory reflex which relaxes the anal sphincter in response to rectal distension) and sensory thresholds (first senstation, | Diagnostic test | All interventions, Sham applied first, All interventions, effective stim applied first |
Primary outcome
ARM outcome - Rectal wall tension
Time frame: Up to three weeks after enrollment
When an organ relaxes during filling it is called compliance and is characteristic of the rectum and bladder. This allows the organ to hold more material and therefore have a larger void when emptying. After SCI, organs that have had their control systems damaged become spastic and hyperreflexive which leads to smaller volumes and incontinence issues in both bladder and bowel function. By inflating the ARM balloon with air we can slightly distend the rectum and measure the pressure (cmH20) to determine compliance. If the pressure stays the same after inflating the balloon then the rectum has relaxed and it is a measure of compliance. Rectal wall tension will be inferred from this response and abnormal tension will be apparent by reduced compliance (pressure increases when balloon volume increases). This measure will be recorded with and without stimulation.
ARM outcome - Anal sphincter function
Time frame: Up to three weeks after enrollment
Circumferential sensors on the ARM balloon catheter will detect pressure changes (cmH20) in the anal sphincter during cough, push, squeeze, and rest. Anal sphincter function will be assessed with and without stimulation.
ARM outcome - Rectoanal reflex activity (RAIR)
Time frame: Up to three weeks after enrollment
Air will be infused into the ARM balloon to distend the rectum. When the rectum is distended the anal sphincter relaxes (rectoanal inhibitory reflex) and the amount of air required to elicit the reflex (cc) will be assessed with and without stimulation.
ARM outcome - Rectal sensation
Time frame: Up to three weeks after enrollment
Air is infused (50 ml steps) into the ARM balloon until the participant reports: first sensation, urge to defecate, maximum tolerable sensation. The volume of air (cc) is recorded for each sensory event with and without stimulation.
ARM outcome - Presence of hyper reflexive rectal contractions
Time frame: Up to three weeks after enrollment
After SCI the rectum become hyperreflexive and spastic. A major cause of fecal incontinence after injury is the result of these reflexive contractions and the inability to contract the external sphincter to maintain continence. This combination causes the rectum to expel small amounts of stool rather than storing the material for a larger bowel movement. We will quantify the rectal pressure traces for reflexive contractions and measure their frequency (Hz or count/minute, whichever is most appropriate). Reflexive contractions will be steep increases in rectal pressure while at rest or during distension (sensation and RAIR testing). Measurements will be collected with and without stimulation and compared.
11 secondary outcomes
SCI-QOL Bowel Management Difficulties (SCI-QOL BMD)
Time frame: During enrollment, up to one week
International SCI Bowel Function Basic Dataset Version 2.1 (ISCI BF BDS)
Time frame: During enrollment, up to one week
International Standards of Neurological Classification of SCI (ISNCSCI)
Time frame: During enrollment, up to one week
SCI Common Data Elements - Medical history
Time frame: During enrollment, up to one week
SCI Common Data Elements - History of injury
Time frame: During enrollment, up to one week
SCI Common Data Elements - Demographics
Time frame: During enrollment, up to one week
Clinical exam - abdominal exam
Time frame: During enrollment, up to one week
Clinical exam - Evaluation of sacral reflexes
Time frame: During enrollment, up to one week
Clinical exam - Anal sphincter tone
Time frame: During enrollment, up to one week
Clinical exam - Sensation
Time frame: During enrollment, up to one week
Clinical exam - Voluntary contraction
Time frame: During enrollment, up to one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. A deidentified set will be transferred to the Inter-University Consortium for Political and Social Research (ICPSR) for data sharing and long-term preservation.
Related trials for Fecal Incontinence
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kim Anderson, PhD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genital Nerve Stimulation, Clinical exam and Collection of SCI common data elements in people with Fecal Incontinence, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mayson Moore (2169573558, MMoore12@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARM outcome - Rectal wall tension (time frame: Up to three weeks after enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.